Delsym

Delsym
SPL v1
SPL
SPL Set ID 671b249d-60f8-450d-8888-269552339b2f
Route
ORAL
Published
Effective Date 2012-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Polistirex Citric Acid Monohydrate Edetate Disodium Ethylcelluloses Fd&c Yellow No. 6 High Fructose Corn Syrup Methylparaben Polyethylene Glycol 3350 Polysorbate 80 Propylene Glycol Propylparaben Water Sucrose Tragacanth Xanthan Gum

Identifiers & Packaging

Marketing Status
NDA Active Since 2009-03-13

Description

Drug Facts

Purpose

Cough suppressant


Medication Information

Purpose

Cough suppressant

Description

Drug Facts

Uses

temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the impulse to cough to help you get to sleep
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

Section 50570-1

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • shake bottle well before use
  • measure only with dosing cup provided. Do not use dosing cup with other products.
  • dose as follows or as directed by a doctor
  • mL = milliliter
adults and children 12 years of age and over 10 mL every 12 hours,

not to exceed 20 mL in 24 hours
children 6 to under 12 years of age 5 mL every 12 hours,

not to exceed 10 mL in 24 hours
children 4 to under 6 years of age 2.5 mL every 12 hours,

not to exceed 5 mL in 24 hours
children under 4 years of age do not use
Questions?

1-888-963-3382     You may also report side effects to this phone number.

Other Information
  • each 5 mL contains: sodium 7 mg
  • store at 20°-25°C (68°-77°F)
  • dosing cup provided
Inactive Ingredients

citric acid, edetate disodium, ethylcellulose, FD&C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, vegetable oil, xanthan gum

Active Ingredient (in Each 5 Ml)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Ask A Doctor Before Use If You Have
  • chronic cough that lasts as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 89 Ml Bottle Carton

NDC 54868-6003-0

Delsym ®

Dextromethorphan Polistirex

Extended-Release Suspension (Cough Suppressant)

COUGH

DAY

OR

NIGHT

12

HOUR

COUGH RELIEF

Orange

Flavored Liquid

89 mL (3 fl oz)

Alcohol-free


Structured Label Content

Uses

temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the impulse to cough to help you get to sleep
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

Section 50570-1 (50570-1)

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Cough suppressant

Directions
  • shake bottle well before use
  • measure only with dosing cup provided. Do not use dosing cup with other products.
  • dose as follows or as directed by a doctor
  • mL = milliliter
adults and children 12 years of age and over 10 mL every 12 hours,

not to exceed 20 mL in 24 hours
children 6 to under 12 years of age 5 mL every 12 hours,

not to exceed 10 mL in 24 hours
children 4 to under 6 years of age 2.5 mL every 12 hours,

not to exceed 5 mL in 24 hours
children under 4 years of age do not use
Questions?

1-888-963-3382     You may also report side effects to this phone number.

Other Information (Other information)
  • each 5 mL contains: sodium 7 mg
  • store at 20°-25°C (68°-77°F)
  • dosing cup provided
Inactive Ingredients (Inactive ingredients)

citric acid, edetate disodium, ethylcellulose, FD&C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, vegetable oil, xanthan gum

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • chronic cough that lasts as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 89 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton)

NDC 54868-6003-0

Delsym ®

Dextromethorphan Polistirex

Extended-Release Suspension (Cough Suppressant)

COUGH

DAY

OR

NIGHT

12

HOUR

COUGH RELIEF

Orange

Flavored Liquid

89 mL (3 fl oz)

Alcohol-free


Advanced Ingredient Data


Raw Label Data

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